Navio NPFS02000Recalls & reported problems

Summary

The FDA's MAUDE database contains 202 adverse event reports that list this exact device (DI 00885556628416), received between Aug 23, 2019 and Mar 7, 2025 — classified as 123 injuries, 79 malfunctions.

The most frequently reported specific device problem is “Application Program Problem: Parameter Calculation Error” (41 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 202 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING SET-UP FOR A NAVIO ASSISTED SURGERY, AN UNSPECIFIED ROBOTIC FAILURE OCCURRED. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, BY CHANGE TO MANUAL INSTRUMENTATION. SINCE THE INCIDENT OCCURRED BEFORE THE PROCEDURE, THE PATIENT WAS NOT YET INVOLVED. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21547841 ↗
• MalfunctionMar 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING SET-UP FOR A NAVIO ASSISTED SURGERY, AN UNSPECIFIED ROBOTIC FAILURE OCCURRED. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, BY CHANGED TO MANUAL INSTRUMENTATION. SINCE THE INCIDENT OCCURRED BEFORE THE PROCEDURE, THE PATIENT WAS NOT YET INVOLVED. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21547804 ↗
• MalfunctionMar 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A NAVIO ASSISTED LEFT TKA SURGERY ON (B)(6) 2019, AN UNSPECIFIED TECHNICAL ERROR OCCURRED. THE SURGERY WAS COMPLETED BY CHANGING TO MANUAL PROCEDURE. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21537837 ↗
• InjuryNov 29, 2023Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT DURING SET-UP FOR A NAVIO-ASSISTED PROCEDURE, THE NAVIO SURGICAL SYSTEM US FAILED TO TURN ON. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, CHANGING TO MANUAL PROCEDURE. AS THIS HAPPENED BEFORE SURGERY, PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18234378 ↗
• InjurySep 5, 2023Application Program Problem: Parameter Calculation Error; Application Program Problem: Parameter Calculation Error

  IT WAS REPORTED THAT, DURING A NAVIO ASSISTED TKA SURGERY, ON THE GAP PLANNING AND SIZING SCREENS IT WAS SHOWING THE FREE IMAGE VERY FAR OFF FROM THE IMPLANT. THE SURGERY WAS COMPLETED, AFTER A NON SIGNIFICANT DELAY, CHANGING TO MANUAL PROCEDURE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17687429 ↗
• InjurySep 5, 2023Application Program Problem: Parameter Calculation Error; Application Program Problem: Parameter Calculation Error

  IT WAS REPORTED THAT, DURING A NAVIO ASSISTED TKA SURGERY, ON THE GAP PLANNING AND SIZING SCREENS IT WAS SHOWING THE FREE IMAGE VERY FAR OFF FROM THE IMPLANT. THE SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, SWITCHING OVER TO TRADITIONAL EQUIPMENT. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17687384 ↗
• MalfunctionJun 5, 2023Computer Operating System Problem; Computer Operating System Problem

  IT WAS REPORTED THAT DURING SET-UP FOR A NAVIO-ASSISTED UKR, THE NAVIO SURGICAL SYSTEM US FAILED TO BOOT UP. SYSTEM REPORTED HARD DOWN. A DELAY GREATER THAN 30 MIN WAS REPORTED. SURGERY WAS CANCELLED. AS THIS HAPPENED BEFORE, PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17059057 ↗
• InjuryMay 24, 2023Overheating of Device; Unintended Application Program Shut Down; Overheating of Device; Unintended Application Program Shut Down

  IT WAS REPORTED THAT DURING A NAVIO-ASSISTED TKA, THERE WAS AIR COMING OUT OF THE DRILL CONNECTION ON THE NAVIO. THIS EVENTUALLY STOPPED/LESSENED. IT WAS MAPPED AND PLANNED THE CASE AND AS MOVED FORWARD TO CUT IT WAS RECEIVED AN INTERNAL CAB ONE/DRILL CONSOLE ERROR. THE CASE WAS QUITTED, RESUMED, SWAPPED THE DRILL - WHICH ALSO NOTICED WAS OSCILLATING - MADE IT TO THE CUT SCREEN AND RECEIVED THE SAME ERROR. AT THIS POINT THE ANSPACH CONTROL COMPLETELY SHUT DOWN AND WAS UNRECOVERABLE. UNIT WAS REBOOTED AND THE ANSPACH DID NOT INITIALIZE SO COULD NOT PROCEED. SURGEON DECIDED TO FINISH THE CASE MANUALLY AFTER A NON-SIGNIFICANT DELAY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16994008 ↗
• InjuryDec 19, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A NAVIO ASSISTED UKR SURGERY, WHEN THE SURGEON WENT TO BUR THE FEMUR, THE DRILL WOULD NOT SPIN AND THE E2 ERROR WAS SHOWED. THE SURGEON DID NOT HAVE THE BUR ON BONE BEFORE ATTEMPTING TO SPIN IT. TROUBLESHOOTING WAS PERFORMED, INCLUDING VERIFYING IT WAS ON CUT MODE, THE SURGEON REMOVED HIS FOOT FROM THE PEDAL FOR 2-3 SECONDS, AND ATTEMPTING TO VERIFY THE BUR COULD SPIN IN A NO LOAD SITUATION. FINALLY THE DRILL WAS UNPLUGGED FROM THE NAVIO CART AND TRIED TO RECONNECT IT. NONE OF THESE CLEARED THE ERROR. A HANDPIECE TEST, AND DRILL TEST WERE CONDUCTED PRIOR TO THE CASE AND BOTH TESTS PASSED. AFTER THE CASE, THE DRILL TEST FAILED FOR THIS DRILL. UPON A SYSTEM RESTART THE DRILL FUNCTIONED NORMALLY. THE CASE WAS RE-ENTERED AND AGAIN THE DRILL WAS ABLE TO SPIN. AFTER TESTING THE DRILL FROM THE OTHER TRAY WITH THE DRILL TEST, IT FAILED TWO TIMES. AT THE THIRD ATTEMPT THE DRILL WORKED AFTER HAVING A FOOT ON THE PEDAL FOR SEVERAL SECONDS. SURGERY WAS PERFORMED MANUALLY AFTER A NON-SIGNIFICANT DELAY. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16011178 ↗
• InjuryNov 12, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A NAVIO-ASSISTED TKA PROCEDURE, UPON GOING TO PERFORM BONE PREP, THE ANSPACH EMAX 2 PLUS HAND PIECE - ROHS WOULD NOT SPIN. IT WAS UNPLUGGED THE DRILL AND PLUGGED IT BACK IN AS WAS NOTICED THE ANSPACH CONSOLE LIGHTS WERE NOT ILLUMINATED. THEN EXITED THE CASE AND CAME BACK IN. THIS DID NOT WORK. THEY CHECKED THE CABLES IN THE BACK OF THE CART AND RESTART IT. SURGERY WAS RESUMED AFTER A NON-SIGNIFICANT, WITH MANUAL INSTRUMENTS. PATIENT WAS NOT HARMED. AFTERWARDS, THEY WERE ABLE TO GET THE CONSOLE TO FUNCTION AFTER RESTARTING IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15785839 ↗
• InjuryNov 12, 2022Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING THE SET-UP FOR A NAVIO ASSISTED SURGERY, A NAVIO SURGICAL SYSTEM US WAS UNABLE TO CALIBRATE HANDPIECE DUE TO CONNECTION ERROR. TWO DIFFERENT HANDPIECES WERE ATTEMPTED AND RAN HANDPIECE TEST ON BOTH BEFORE ATTEMPTING TO CALIBRATE. BOTH HANDPIECES PASSED INITIAL TESTING BUT COULD NOT CALIBRATE AND BURR WAS INSTALLED PROPERLY. SURGERY WAS PERFORMED AFTER A NON-SIGNIFICANT DELAY AND CHANGING TO A MANUAL PROCEDURE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15785838 ↗
• InjuryOct 23, 2022Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT, DURING SET UP FOR A NAVIO ASSISTED SURGERY, WHEN TRYING TO POWER ON THE NAVIO SURGICAL SYSTEM, THEY KEPT RECEIVING AN ERROR CODE OF UPS BACK UP ERROR CODE NOT WORKING PROPERLY. REP TRIED LEAVING IT ON PLUGGED IN CHARGED BUT STILL WOULDN¿T START. EVERYTHING WAS PLUGGED IN. REP THEN TRIED BYPASSING THE UPS AND PLUGGING IT IN THE WALL BUT STILL DIDN¿T WORK. THE PROCEDURE WAS COMPLETED WITH MANUAL INSTRUMENTATIONS WITHOUT DELAYS. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15656516 ↗
• InjuryOct 5, 2022Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT NAVIO SURGICAL SYSTEM US WAS STUCK ON THE INITIAL START SCREEN AND WOULD NOT ADVANCE PRIOR TO THE CASE STARTING. THE REPRESENTATIVE STILL COULD NOT ADVANCE THE SCREEN BEFORE THE PATIENT GOT IN THE ROOM. THE CASE WAS CANCELLED BECAUSE OF THIS ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 15547063 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE LITERATURE REVIEW "INITIAL SAFETY PROFILE ASSESSMENT OF THE NAVIO ROBOTIC-ASSISTED TOTAL KNEE ARTHROPLASTY", IT WAS REPORTED THAT, AFTER UNDERGOING A NAVIO-ASSISTED RA-TKA PROCEDURE, ONE (1) PATIENT EXPERIENCED A FALL RESULTING IN A PERI-PROSTHETIC FRACTURE. IT IS UNKNOWN HOW THIS ADVERSE EVENT WAS TREATED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 15251338 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE LITERATURE REVIEW " INITIAL SAFETY PROFILE ASSESSMENT OF THE NAVIO ROBOTIC-ASSISTED TOTAL KNEE ARTHROPLASTY ", IT WAS REPORTED THAT, AFTER UNDERGOING A NAVIO-ASSISTED RA-TKA PROCEDURE, FOUR (4) PATIENTS UNDERWENT MANIPULATION UNDER ANESTHESIA. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15251010 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE LITERATURE REVIEW " INITIAL SAFETY PROFILE ASSESSMENT OF THE NAVIO ROBOTIC-ASSISTED TOTAL KNEE ARTHROPLASTY ", IT WAS REPORTED THAT, AFTER UNDERGOING A NAVIO-ASSISTED RA-TKA PROCEDURE, ONE (1) PATIENT EXPERIENCED DEEP INFECTION. IT IS UNKNOWN HOW THIS ADVERSE EVENT WAS TREATED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 15250870 ↗
• InjuryAug 9, 2022Circuit Failure; Circuit Failure

  IT WAS REPORTED THAT BEFORE A NAVIO ASSISTED SURGERY, THEY KEPT RECEIVING PFS FAILURE, AND TRIED ALL TROUBLESHOOTING SUGGESTED, BUT THE CONSOLE DID NOT WORK. IT WAS CONCLUDED THAT FAILURE OCCURRED DUE TO A BLOWN SIU. PROCEDURE WAS PERFORMED, AFTER A DELAY GREATER THAN 30 MINUTES, BY CHANGING TO MANUAL PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15195885 ↗
• MalfunctionJul 10, 2022Application Program Problem: Parameter Calculation Error; Application Program Problem: Parameter Calculation Error

  IT WAS REPORTED THAT DURING A NAVIO ASSISTED CASE, WHEN SURGEON TRIED TO CUT THE TIBIA, IT LOOKED OFF. THEY DID NOT CUT AS HANDPIECE WAS IN AIR REMOVING BONE. IT WAS TRIED TO GO BACK TO RECOLLECT, ALL CHECKPOINTS WERE CORRECT AND HANDPIECE TRACKER WAS NOT LOOSE. SURGEON CHOSE TO START OVER BY COLLECTING INVALID CHECKPOINTS. THE FEMUR WAS CUT AT THIS STAGE, SO THAT DATA IS NOT GOOD. THEY ADJUSTED THE TIBIA PLAN AND THERE WAS NO ISSUE TO CUT IT. THE SURGEON WAS SATISFIED WITH THE TIBIA CUT AND FEMUR CUT, BUT DOWNSIZED THE FEMUR AND MOVED THE IMPLANT MANUALLY TO ACCOUNT FOR THE PEGHOLE ISSUE. PROCEDURE WAS PERFORMED WITH A DELAY GREATER THAN 30 MINUTES AND PATIENT WAS NOT HARMED BEYOND THE DESCRIBED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14973835 ↗
• InjuryJun 11, 2022Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT, DURING NAVIO ASSISTED SURGERY, THE NAVIO GOT "STUCK" ON THE TIBIAL SCREENS NOT ALLOWING TO GO TO FEMUR TO VISUALIZE THE DISTAL FEMORAL CUT. THE NAVIO WAS REBOOTED, STARTED A NEW CASE, CALIBRATED, MAPPED, AND PLANNED WITHOUT ISSUE. PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, BY CHANGING TO MANUAL. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14670066 ↗
• InjuryJun 9, 2022Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A NAVIO ASSISTED PFA SURGERY, THEY RECEIVED AN "UNABLE TO COMMUNICATE WITH HANDPIECE" MESSAGE WITH THREE DIFFERENT NAVIO HANDPIECES. THE PROCEDURE WAS COMPLETED WITH MANUAL INSTRUMENTS WITHOUT DELAY. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14645426 ↗
• InjuryJun 7, 2022Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT, WHEN CALIBRATING THE NAVIO HANDPIECE DURING A NAVIO ASSISTED TKA SURGERY, THERE WERE SEVERAL ERROR MESSAGES STATING ¿CANNOT RECOGNIZE HANDPIECE". AFTER TROUBLE SHOOTING, THE HANDPIECE WAS CALIBRATED. THE CASE CONTINUED THROUGH PLANNING, MADE ANTERIOR FEMORAL BURR HOLES, TRIED TO ADVANCE TO MAKE THE TIBIAL BURR HOLES AND THE NAVIO FROZE. WHEN RETURNING TO THE PLANNING SCREEN, THE BUTTON WERE GREYED OUT AND COULD NOT CLICK ON THEM. AFTER REBOOTING THE NAVIO, THE HANDPIECE COULD NOT BE CALIBRATED. PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, BY CHANGING TO MANUAL PROCEDURE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14626714 ↗
• InjuryJan 27, 2022Circuit Failure; Circuit Failure

  IT WAS REPORTED THAT WHILE PREPARING FOR A NAVIO ASSISTED TKA SURGERY, THE NAVIO SURGICAL SYSTEM US BOOTED UP AS EXPECTED BUT, WHEN THE ATTEMPT WAS MADE TO HOME THE BUR THEY RECEIVED A MESSAGE SAYING "INTERNAL CABLING/DRILL CONSOLE ERROR". AFTER THEY REBOOTED, THEY GOT AN ERROR MESSAGE CAME UP SAYING "PFS CONTROL HARDWARE FAILURE". THEY SHUT DOWN THE MACHINE, UNPLUGGED EVERYTHING AND REBOOTED, BUT THE SAME ERROR MESSAGE CAME UP BEFORE THE START SCREEN WOULD APPEAR THEREFORE FORBIDDING THEM FROM ENTERING A CASE. ANOTHER REBOOT WAS ATTEMPTED WITH THE SAME ERROR MESSAGE. THE PROCEDURE WAS COMPLETED WITH MANUAL INSTRUMENTATION WITHOUT SIGNIFICANT DELAYS. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM. ADDITIONALLY, THEY LEFT THE NAVIO PLUGGED IN FOR 15 MINUTES AND TRIED STARTING IT UP BUT THE SAME MESSAGE CAME UP, FORBIDDING THEM FROM ENTERING THE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13365079 ↗
• MalfunctionDec 29, 2021Computer Operating System Problem; Computer Operating System Problem

  IT WAS REPORTED THAT, DURING A NAVIO ASSISTED SURGERY, AN ERROR APPEARED AND THE SCREEN STARTED HAVING LINES GO ACROSS THE SCREEN THAT KEPT MULTIPLYING. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13113048 ↗
• MalfunctionDec 10, 2021Circuit Failure; Circuit Failure

  IT WAS REPORTED THAT DURING AN INSPECTION OF A NAVIO, THE NAVIO SURGICAL SYSTEM US HAD AN ERROR DURING INITIALIZATION: PFS HARDWARE FAILURE 40000000000. SINCE THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12975759 ↗
• InjuryDec 8, 2021Misassembly by Users; Misassembly by Users

  IT WAS REPORTED THAT, DURING SET UP FOR A NAVIO ASSISTED PFA, THEY PLUGGED THE NAVIO SURGICAL SYSTEM US WITHOUT THE MONITOR PLUGGED IN AND COULD NOT GET NAVIO SCREENS TURNED ON. ¿NO SIGNAL DETECTED¿ ERROR SCREENS POPULATED ON THE MONITOR AFTER 1 BEEP AND THEN 4 ADDITIONAL BEEPS. THEY DID A SHUT DOWN AND RESTART, SAME ISSUE. THEY TRIED USING A DIFFERENT OUTLET FOR THE POWER CORD, AND HAD THE SAME ISSUE. THEY TRIED UNPLUGGING THE PLUG INSIDE THE NAVIO CONNECTED TO THE FUSE BOX AND PLUGGING IT INTO THE WALL OUTLET, AND HAD SAME ISSUE. THEY CONTACTED ROBOTICS SUPPORT AND TRIED EVERY OPTION POSSIBLE, AND STILL HAVING THE SAME ISSUE. THE PROCEDURE WAS COMPLETED WITH MANUAL INSTRUMENTATION WITHOUT SIGNIFICANT DELAYS. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM. AFTER THE CASE, THEY PLUGGED THE NAVIO INTO THE HALLWAY OUTLET AND SOMEHOW, THE NAVIO STARTED WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12964471 ↗